Metastatic Breast CancerPhase 1NCT01802970
Safety and Blood Immune Cell Study of Anakinra Plus Physician's Chemotherapy Choice in Metastatic Breast Cancer Patients
A Phase 1 study of Metastatic Breast Cancer, run by Baylor Research Institute at 1 site in United States.
Trial summary
To determine the safety of administering anakinra plus the physician's chemotherapy choice (TPC) of nab paclitaxel, capecitabine, eribulin, or vinorelbine in patients with metastatic breast cancer (MBC), as well as determining blood immune cell transcriptional signatures in patients who undergo IL-1 receptor blockade. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Metastatic Breast Cancer
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to 4 Jan 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or male patients ≥18 years of age.
- Histologically confirmed invasive breast cancer, locally unresectable or metastatic.
- No more than 4 prior chemotherapy regimens for metastatic disease.
- Patients currently being treated with nab paclitaxel, capecitabine,eribulin, or vinorelbine who have had a CR, PR, or SD and who have developed Grade 2, 3, or 4 fatigue on the chemotherapy are eligible for the study. It should be anticipated that these patients will continue to be treated on the same chemotherapy agent for at least 3 more months beyond the time of enrollment.
- Prior hormonal therapy in the adjuvant or metastatic setting is permitted.
- HER2-negative breast cancer. If HER2-, it is defined as follows:
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- FISH-negative (FISH ratio <2.0), or
- IHC 0-1+, or
- IHC 2+ AND FISH-negative (FISH ratio<2.0)
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
- Adequate hematologic function, defined by:
- Absolute neutrophil count (ANC) >1500/mm^3
- Platelet count ≥100,000/mm^3
- Hemoglobin >8 g/dL
- Adequate liver function, defined by:
- AST and ALT ≤2.5 x the upper limit of normal (ULN) or ≤5 x ULN in presence of liver metastases
- Total bilirubin ≤1.5 x ULN
- Adequate renal function, defined by:
- Serum creatinine ≤1.5 x ULN or calculated creatinine clearance of ≥40 ml/min
- Measurable or nonmeasurable disease by RECIST v1.1 criteria
- Life expectancy ≥24 weeks
- Adequate recovery from recent surgery
- Major surgical procedure >28 days from study entry
- Minor surgical procedure >7 days from study entry (Portacath placement accepted - patients can start treatment <7 days after portacath placement.)
- Patients with previous history of invasive cancers (including breast cancer) are eligible if definitive treatment was completed more than 5 years prior to initiating current study treatment, and there is no evidence of recurrent disease.
- Patient must be accessible for treatment and follow-up.
- All patients must be able to understand the investigational nature of the study and give written informed consent prior to study entry
Who cannot join
- Patients with active or untreated brain metastases or meningeal metastases are ineligible. Patients who have had brain metastases resected, or have received brain radiation therapy >4 weeks prior to study entry are eligible if they meet all of the following criteria: 1) patient has been off dexamethasone for >2 weeks; 2) no known progression of brain metastasis.
- Previous radiotherapy for metastatic disease completed <2 weeks prior to study treatment initiation.
- Women who are pregnant or lactating. All patients with reproductive potential must agree to use effective contraception from time of study entry until at least 3 months after the last administration of study drug.
- Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation such as: -
- severe impaired lung functions as defined as spirometry and DLCO that is 50% of the normal predicted value and/or O2 saturation that is 88% or less at rest on room air
- uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN
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- liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C).
- History of any other disease, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug, or that might affect interpretation of the results of this study, or render the subject at high risk for treatment complications.
- Patients may not receive any other investigational treatments while participating in this study.
- Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent. Topical or inhaled corticosteroids are allowed.
- Concurrent severe, uncontrolled infection or intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor University Medical Center
Dallas, Texas, 75246
About this study
Official title: Pilot Safety and Blood Immune Cell Transcriptional Profiling Study of Anakinra Plus the Physician's Chemotherapy Choice in Metastatic Breast Cancer Patients
To determine the safety of administering anakinra plus the physician's chemotherapy choice (TPC) of nab paclitaxel, capecitabine, eribulin, or vinorelbine in patients with metastatic breast cancer (MBC), as well as determining blood immune cell transcriptional signatures in patients who undergo IL-1 receptor blockade.
Read the detailed description
In an attempt to reverse the immune suppressive microenvironment and to enhance chemotherapy effectiveness, decrease tumor metagenicity and decrease IL-1-induced fatigue, metastatic breast cancer (MBC) patients will be treated with chemotherapy plus anakinra. This is a pilot safety, single arm, open label trial. The objective is to determine the safety of anakinra plus the physician's chemotherapy choice (TPC) of nab paclitaxel, capecitabine, eribulin, or vinorelbine in patients with MBC and to define an anakinra-induced anti-IL-1 whole blood transcriptional profile.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Anakinra plus Standard of Care
- Keywords
- Anakinra, Nab Paclitaxel, Capecitabine, Eribulin, Vinorelbin
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anakinra plus Standard of CareDrug
Also called Anakinra: kineret, Nab paclitaxel: Abraxane, Capecitabine: Xeloda, Eribulin: Halaven
Patients will undergo a 2-week run-in treatment of daily anakinra alone. This will be followed by daily anakinra (100 mg SC) plus the physician's chemotherapy ( TPC) choice of standard of care (SOC) for a maximum of 6 months.TPC choice includes nab paclitaxel (100 mg/m^2 Intravenous on day 1,8 \&15 of a 28 day cycle), or capecitabine (1000mg/m^2 per oral; BID choice: 14 days on, 7 days off OR 7 days on, 7 days off of a 21 day cycle), or eribulin (1.4 mg/m^2 intravenous on day 1 \& 8 of a 21 day cycle), or vinorelbine (25mg/m^2 on day 1,8,15 of a 28 day cycle). After 6 months, patients may continue their SOC treatment alone until disease progression or intolerable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Anakinra plus Standard of Care | Experimental | Patients will undergo a 2-week run-in treatment of daily anakinra alone. This will be followed by daily anakinra (100 mg SC) plus the physician's chemotherapy ( TPC) choice of standard of care (SOC) for a maximum of 6 months.TPC choice includes nab paclitaxel (100 mg/m^2 Intravenous on day 1,8 \&15 of a 28 day cycle), or capecitabine (1000mg/m^2 per oral; BID choice: 14 days on, 7 days off OR 7 days on, 7 days off of a 21 day cycle), or eribulin (1.4 mg/m^2 intravenous on day 1 \& 8 of a 21 day cycle), or vinorelbine (25mg/m^2 on day 1,8,15 of a 28 day cycle). After 6 months, patients may continue their SOC treatment alone until disease progression or intolerable toxicity. Receives: Drug: Anakinra plus Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Adverse Events in participants
Patients will receive anakinra plus the physicians chemotherapy choice of nab paclitaxel, or capecitabine, or eribulin, or vinorelbine for metastatic breast cancer. Adverse events will be recorded throughout the trial, and regardless of the severity will be followed up by investigator until resolution is satisfactory. All adverse events and toxicities will be recorded and assessed for 30 days following the last dose of anakinra at a maximum of 6 months. Grading will be done using Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Measured: up to 7 months
Secondary outcomes (1)
To determine investigator-assessed objective response rate, clinical benefit rate, progression-free survival, and rates of chemotherapy or cancer-related anemia (HgB<10), and an anakinra-induced anti-IL-1 blood transcriptional signatures
Objective response rate, clinical benefit rate and progression-free survival in patients will be determined using radiological assessment of tumors (CT/MRI/X-ray/PET), clinical and functional evaluation of patients with 95% confidence intervals. Whole blood transcriptional profiling will be performed to determine a gene expression signature that is induced by IL-1 receptor blockade by anakinra. The gene expression signatures from baseline will be compared to those signatures obtained after the 2-week run-in treatment with anakinra alone. During the treatment, complete blood count with differential/platelet count and complete metabolic profiling will be done to identify any baseline changes.
Measured: upto 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2013 (estimated)
- Study startDec 2012
- Primary completion4 Jan 2017
- Study completion4 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joyce O'Shaughnessy, MD, Principal investigator, Baylor Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01802970
- Sponsor's protocol ID
- 012-099
- Status last verified
- Oct 2021
- First submitted
- 28 Feb 2013
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Safety and Blood Immune Cell Transcriptional Profiling Study of Anakinra Plus the Physician's Chemotherapy Choice in Metastatic Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT01802970
- Acronym / sponsor ID
- 012-099
- Conditions
- Metastatic Breast Cancer
- Keywords
- Anakinra, Nab Paclitaxel, Capecitabine, Eribulin, Vinorelbin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- 4 Jan 2017 (actual)
- Study completion
- 4 Jan 2017 (actual)
- First posted
- 4 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the safety of administering anakinra plus the physician's chemotherapy choice (TPC) of nab paclitaxel, capecitabine, eribulin, or vinorelbine in patients with metastatic breast cancer (MBC), as well as determining blood immune cell transcriptional signatures in patients who undergo IL-1 receptor blockade.
Detailed description
In an attempt to reverse the immune suppressive microenvironment and to enhance chemotherapy effectiveness, decrease tumor metagenicity and decrease IL-1-induced fatigue, metastatic breast cancer (MBC) patients will be treated with chemotherapy plus anakinra. This is a pilot safety, single arm, open label trial. The objective is to determine the safety of anakinra plus the physician's chemotherapy choice (TPC) of nab paclitaxel, capecitabine, eribulin, or vinorelbine in patients with MBC and to define an anakinra-induced anti-IL-1 whole blood transcriptional profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anakinra plus Standard of Care | Experimental | Drug: Anakinra plus Standard of CarePatients will undergo a 2-week run-in treatment of daily anakinra alone. This will be followed by daily anakinra (100 mg SC) plus the physician's chemotherapy ( TPC) choice of standard of care (SOC) for a maximum of 6 months.TPC choice includes nab paclitaxel (100 mg/m^2 Intravenous on day 1,8 \&15 of a 28 day cycle), or capecitabine (1000mg/m^2 per oral; BID choice: 14 days on, 7 days off OR 7 days on, 7 days off of a 21 day cycle), or eribulin (1.4 mg/m^2 intravenous on day 1 \& 8 of a 21 day cycle), or vinorelbine (25mg/m^2 on day 1,8,15 of a 28 day cycle). After 6 months, patients may continue their SOC treatment alone until disease progression or intolerable toxicity. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Female or male patients ≥18 years of age.
- Histologically confirmed invasive breast cancer, locally unresectable or metastatic.
- No more than 4 prior chemotherapy regimens for metastatic disease.
- Patients currently being treated with nab paclitaxel, capecitabine,eribulin, or vinorelbine who have had a CR, PR, or SD and who have developed Grade 2, 3, or 4 fatigue on the chemotherapy are eligible for the study. It should be anticipated that these patients will continue to be treated on the same chemotherapy agent for at least 3 more months beyond the time of enrollment.
- Prior hormonal therapy in the adjuvant or metastatic setting is permitted.
Key exclusion criteria (11 listed)
- Patients with active or untreated brain metastases or meningeal metastases are ineligible. Patients who have had brain metastases resected, or have received brain radiation therapy >4 weeks prior to study entry are eligible if they meet all of the following criteria: 1) patient has been off dexamethasone for >2 weeks; 2) no known progression of brain metastasis.
- Previous radiotherapy for metastatic disease completed <2 weeks prior to study treatment initiation.
- Women who are pregnant or lactating. All patients with reproductive potential must agree to use effective contraception from time of study entry until at least 3 months after the last administration of study drug.
- Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation such as: -
- History of any other disease, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug, or that might affect interpretation of the results of this study, or render the subject at high risk for treatment complications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anakinra plus Standard of CareAlso: Anakinra: kineret, Nab paclitaxel: Abraxane, Capecitabine: Xeloda, Eribulin: HalavenPatients will undergo a 2-week run-in treatment of daily anakinra alone. This will be followed by daily anakinra (100 mg SC) plus the physician's chemotherapy ( TPC) choice of standard of care (SOC) for a maximum of 6 months.TPC choice includes nab paclitaxel (100 mg/m^2 Intravenous on day 1,8 \&15 of a 28 day cycle), or capecitabine (1000mg/m^2 per oral; BID choice: 14 days on, 7 days off OR 7 days on, 7 days off of a 21 day cycle), or eribulin (1.4 mg/m^2 intravenous on day 1 \& 8 of a 21 day cycle), or vinorelbine (25mg/m^2 on day 1,8,15 of a 28 day cycle). After 6 months, patients may continue their SOC treatment alone until disease progression or intolerable toxicity. | Drug | Anakinra plus Standard of Care |
Primary outcome
Safety - Adverse Events in participants
Time frame: up to 7 months
Patients will receive anakinra plus the physicians chemotherapy choice of nab paclitaxel, or capecitabine, or eribulin, or vinorelbine for metastatic breast cancer. Adverse events will be recorded throughout the trial, and regardless of the severity will be followed up by investigator until resolution is satisfactory. All adverse events and toxicities will be recorded and assessed for 30 days following the last dose of anakinra at a maximum of 6 months. Grading will be done using Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
1 secondary outcome
To determine investigator-assessed objective response rate, clinical benefit rate, progression-free survival, and rates of chemotherapy or cancer-related anemia (HgB<10), and an anakinra-induced anti-IL-1 blood transcriptional signatures
Time frame: upto 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joyce O'Shaughnessy, MD principal investigator
Baylor Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Metastatic Breast Cancer, run by Baylor Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety - Adverse Events in participants (time frame: up to 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2021.